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510(k) Data Aggregation
(131 days)
ACCU-CHEK AVIVA PLUS SYSTEM
The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
The modified ACCU-CHEK Aviva meter used in conjunction with the ACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meter no longer uses a code key.
The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions
Here's an analysis of the provided text regarding the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System, focusing on acceptance criteria and study details.
Based only on the provided text, the specific details regarding the acceptance criteria and a detailed study proving the device meets them are very limited. The document is primarily a 510(k) summary for a modified device, emphasizing its substantial equivalence to a predicate device.
Here's what can be extracted and what is explicitly not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting performance requirements and being substantially equivalent to the predicate device.
| Performance Metric | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (General Statement) |
|---|---|---|
| Accuracy of glucose measurement | (Not explicitly stated, but implied to be comparable to predicate) | "Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use." |
| Precision/Reproducibility | (Not explicitly stated) | Implied to be acceptable as part of meeting "performance requirements for its intended use." |
| Usability for self-testing | (Not explicitly stated) | Implied to be acceptable for "self testing outside the body (in vitro diagnostic use) by people with diabetes at home." |
| Performance across various blood draw sites (fingertips, forearm, upper arm, palm) | (Not explicitly stated) | The device is "intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document only states "Performance testing on the ACCU-CHEK Aviva System demonstrated..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given text. For blood glucose monitoring systems, ground truth is typically established using a high-precision laboratory reference method, not necessarily by human experts in the same way it would be for imaging diagnostics. The text does not elaborate on the method used to establish reference glucose values.
4. Adjudication method
This information is not provided in the given text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, which typically does not involve human "readers" interpreting results in the same way an imaging AI system would. Its primary function is to provide a quantitative measurement.
- AI Improvement Effect Size: Not applicable. There is no mention of AI integration in this blood glucose monitoring system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system in the sense that the meter provides the glucose reading without requiring human interpretation or intervention beyond performing the test procedure. However, the document does not distinguish between "standalone algorithm performance" and "system performance" as it might for an AI-driven diagnostic. The "performance testing" referred to would inherently be of the "algorithm only" (i.e., the device's measurement capability) without a human interpreting the result to determine the glucose level.
7. The type of ground truth used
The type of ground truth is not explicitly stated beyond the implication that it's a quantitative measurement of glucose. For blood glucose meters, the ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) known for its high accuracy. The text only mentions "quantitative measurement of glucose (sugar)."
8. The sample size for the training set
This information is not provided in the given text. Blood glucose meters are not typically "trained" in the same way a machine learning algorithm would be. Their performance is based on the chemical and electrical design of the test strip and meter. If any statistical models or calibrations were involved, the training set details are omitted.
9. How the ground truth for the training set was established
This information is not provided in the given text. (See point 8 regarding "training set.")
Summary of Limitations due to Document Scope:
The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device for a modified blood glucose monitoring system (specifically, a meter that no longer uses a code key). It states that performance testing was done and that the device "meets the performance requirements for its intended use" and is "substantially equivalent to the predicate device." However, it does not provide detailed technical specifications, exact acceptance criteria, or granular study results (like sample sizes for performance studies, specific ground truth methods, or any statistical analysis) that would be found in a full submission or a detailed study report. These details are often proprietary or contained in other sections of a 510(k) submission not included here.
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